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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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08/14/2015 Sterility 14-465 Complete ISO ASTM 51707 Third edition 2015-03-15 Guide for estimating uncertainties in dosimetry for radiation processing
12/21/2020 Sterility 14-553 Complete ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
12/18/2023 Sterility 14-590 Complete ISO 14644-8 Third edition 2022-06 Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)
01/27/2015 Sterility 14-379 Complete ISO 14644-8 Second edition 2013-02-15 Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
12/23/2019 Sterility 14-538 Complete ASTM F3357-19 Standard Guide for Designing Reusable Medical Devices for Cleanability
08/14/2015 Sterility 14-463 Complete ISO ASTM 51608 Second edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
04/04/2016 Sterility 14-337 Complete ISO 14937 Second edition 2009-10-15 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ANSI AAMI ISO 14937:2009/(R)2013 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
07/06/2020 Sterility 14-539 Complete ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
07/09/2014 Sterility 14-434 Complete ASTM F2228-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
01/27/2015 Sterility 14-456 Complete ANSI AAMI ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 First edition 2014-05-15 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
07/06/2020 Sterility 14-540 Complete ISO 11737-2 Third edition 2019-12 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ANSI AAMI ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
05/29/2023 Sterility 14-586 Complete ISO 22441 First edition 2022-08 Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
07/06/2020 Sterility 14-541 Complete ANSI AAMI ST72:2019 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
07/15/2019 Sterility 14-529 Complete ISO 11135 Second edition 2014-07-15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
ANSI AAMI ISO 11135:2014/A1:2018 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release
09/09/2008 Sterility 14-240 Complete ISO 13408-5 First edition 2006-11-15 Aseptic processing of health care products - Part 5: Sterilization-in-place
ANSI AAMI ISO 13408-5:2006/(R)2015 Aseptic processing of health care products - Part 5: Sterilization in place
08/06/2013 Sterility 14-388 Complete ISO 13408-7 First edition 2012-08-01 Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
ANSI AAMI ISO 13408-7:2012 (R2018) Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
12/23/2016 Sterility 14-500 Complete ISO 14644-1 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
07/09/2014 Sterility 14-433 Complete ASTM F2227-13 (Reapproved 2021) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
05/30/2022 Sterility 14-579 Complete ISO 17664-2 First edition 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.
12/19/2022 Sterility 14-581 Complete ASTM F2638-22 Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier
12/19/2022 Sterility 14-582 Complete AAMI ISO TIR11137-4:2022 Sterilization of health care products - Radiation - Part 4: Guidance on process control
ISO TS 11137-4 First edition 2020-06 Sterilization of health care products - Radiation - Part 4: Guidance on process control
12/19/2022 Sterility 14-583 Complete ANSI AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
01/30/2014 Sterility 14-402 Complete ASTM F1140/F1140M-13 (Reapproved 2020)e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014 Sterility 14-404 Complete ASTM F2250-13 (Reapproved 2018) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
05/30/2022 Sterility 14-574 Complete ASTM F1608-21 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
12/20/2021 Sterility 14-563 Complete ISO 13408-6 Second edition 2021-04 Aseptic processing of health care products - Part 6: Isolator systems
07/06/2020 Sterility 14-542 Complete ISO ASTM 52628 Second edition 2020-04 Standard practice for dosimetry in radiation processing
05/29/2024 Sterility 14-600 Complete ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
06/27/2015 Sterility 14-484 Complete ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
05/29/2024 Sterility 14-601 Complete ISO 17665 First edition 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
05/29/2024 Sterility 14-602 Complete AAMI TIR12:2020/(R)2023 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
05/29/2023 Sterility 14-585 Complete AAMI ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO TS 16775 Second edition 2021-11 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
07/15/2019 Sterility 14-531 Complete ISO 11607-2 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ANSI AAMI ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
12/18/2023 Sterility 14-596 Complete ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Materials
01/27/2015 Sterility 14-242 Complete ISO 14644-3 First edition 2005-12-15 Cleanrooms and associated controlled environments - Part 3: Test methods
12/23/2016 Sterility 14-169 Complete ASTM F2391-05 (Reapproved 2016) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
01/30/2014 Sterility 14-334 Partial ISO 15882 Second edition 2008-09-01 Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
ANSI AAMI ISO 15882:2008/(R)2013 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
01/14/2019 Sterility 14-396 Partial ANSI AAMI ST77:2013/(R)2018 Containment devices for reusable medical device sterilization
05/30/2022 Sterility 14-572 Partial ANSI AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
05/30/2022 Sterility 14-578 Partial ISO 17664-1 First edition 2021-07 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
01/30/2014 Sterility 14-401 Complete ASTM F2217/F2217M-13 (Reapproved 2023) Standard Practice for Coating/Adhesive Weight Determination
01/27/2015 Sterility 14-141 Complete ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
09/17/2018 Sterility 14-293 Complete ANSI AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers
01/14/2019 Sterility 14-518 Complete AAMI ANSI ST55:2016/(R)2023 Table-top steam sterilizers
01/30/2014 Sterility 14-429 Complete ISO ASTM 51275 Third edition 2013-06-01 Practice for use of a radiochromic film dosimetry system
09/17/2018 Sterility 14-512 Complete ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration.
ANSI AAMI ISO 13408-2:2018 Aseptic processing of health care products - Part 2:Sterilizing filtration
09/17/2018 Sterility 14-275 Complete ANSI AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness
07/09/2014 Sterility 14-256 Complete ASTM F2095-07 (Reapproved 2021) Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
12/18/2023 Sterility 14-589 Complete ISO 14644-4 Second edition 2022-11 Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
07/09/2014 Sterility 14-435 Complete ASTM F2251-13 (Reapproved 2023) Standard Test Method for Thickness Measurement of Flexible Packaging Material
06/27/2016 Sterility 14-481 Complete ISO 14644-2 Second edition 2015-12-15 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
06/27/2016 Sterility 14-483 Complete ISO ASTM 52303 First edition 2015-07-15 Guide for absorbed-dose mapping in radiation processing facilities
09/09/2008 Sterility 14-142 Complete ISO 14698-1:2003 Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
05/29/2024 Sterility 14-598 Complete ISO 14644-3 Second edition 2020-06 Cleanrooms and associated controlled environments - Part 3: Test methods
01/30/2014 Sterility 14-406 Complete ANSI AAMI ST8:2013/(R)2018 Hospital steam sterilizers
09/09/2008 Sterility 14-191 Complete ISO 13408-4 First edition 2005-11-01 Aseptic processing of health care products - Part 4: Clean-in-place technologies
ANSI AAMI ISO 13408-4:2005/(R)2014 Aseptic processing of health care products - Part 4: Clean-in-place technologies
01/27/2015 Sterility 14-166 Complete ISO 14644-7 First edition 2004-10-01 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
05/29/2024 Sterility 14-599 Complete ISO 14644-9 Second edition 2022-05 Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration
01/27/2015 Sterility 14-389 Complete ISO 14644-9 First edition 2012-08-15 Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
05/29/2023 Sterility 14-587 Complete AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources
12/18/2023 Sterility 14-592 Complete ISO 13408-1 Third edition 2023-08 Aseptic processing of health care products - Part 1: General requirements
01/30/2014 Sterility 14-427 Complete ISO 13408-1 Second edition 2008-06-15 Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
12/18/2023 Sterility 14-594 Complete ISO 11607-1 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including Amendment 1 (2023)]
12/18/2023 Sterility 14-593 Complete ASTM F3039-23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
09/17/2018 Sterility 14-516 Complete ASTM F3039-15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
07/15/2019 Sterility 14-530 Complete ISO 11607-1 Second edition 2019-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
12/18/2023 Sterility 14-595 Complete ISO 11607-2 Second edition 2019-02 [Including AMD1:2023] Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
05/30/2022 Sterility 14-573 Complete ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials
12/18/2023 Sterility 14-597 Complete AAMI ANSI ST108:2023 Water for the processing of medical devices
01/27/2015 Sterility 14-390 Complete ISO 14644-10 First edition 2013-03-01 Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
10/09/2023 Software/
Informatics		 13-129 Complete ISO IEC IEEE 29119-1 Second edition 2022-01 Software and systems engineering - Software testing - Part 1: General concepts
10/09/2023 Software/
Informatics		 13-131 Complete ANSI AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers
08/06/2013 Software/
Informatics		 13-52 Complete ISO IEEE 11073-10408 First edition 2010-05-01 Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
05/29/2024 Software/
Informatics		 13-133 Complete ISO IEEE 11073-10415 Second edition 2022-12 Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
05/29/2024 Software/
Informatics		 13-137 Complete IEEE Std 11073-10101b-2023 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
07/06/2020 Software/
Informatics		 13-114 Complete IEEE Std 11073-10101-2019 Health informatics - Point-of-care medical device communication. Part 10101: Nomenclature
05/29/2024 Software/
Informatics		 13-135 Complete ISO IEEE 11073-10407 Second edition 2022-12 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
IEEE Std 11073-10407-2020 Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
12/19/2022 Software/
Informatics		 13-126 Complete ANSI AAMI UL 2800-1-2:2022 Standard for Interoperable Item Development Life Cycle
12/19/2022 Software/
Informatics		 13-127 Complete ANSI AAMI UL 2800-1-3:2022 Standard for Interoperable Item Integration Life Cycle
12/19/2022 Software/
Informatics		 13-121 Complete ANSI AAMI UL 2800-1:2022 Standard for Medical Device Interoperability
12/19/2022 Software/
Informatics		 13-125 Complete ANSI AAMI UL 2800-1-1:2022 Standard for Risk Concerns for Interoperable Medical Products
08/14/2015 Software/
Informatics		 13-74 Complete IEEE Std 11073-10424-2014 Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/06/2013 Software/
Informatics		 13-40 Complete ANSI AAMI IEC TIR 80001-2-1 2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
IEC TR 80001-2-1 Edition 1.0 2012-07 Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
08/06/2013 Software/
Informatics		 13-44 Complete ANSI AAMI IEC TIR 80001-2-3:2012 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
07/09/2014 Software/
Informatics		 13-69 Complete ISO IEEE 11073-10472 First edition 2012-11-01 Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor
12/04/2017 Software/
Informatics		 13-101 Complete ISO IEC 15459-6 Second edition 2014 Corrected 2016 Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings
08/21/2017 Software/
Informatics		 13-93 Complete ISO IEEE 11073-10422:2017 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
IEEE Std 11073-10422-2016 Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer
12/20/2021 Software/
Informatics		 13-120 Complete ANSI AAMI 2700-1:2019 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
12/19/2022 Software/
Informatics		 13-122 Complete IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
12/19/2022 Software/
Informatics		 13-123 Complete ANSI NEMA HN 1-2019 American National Standard Manufacturer Disclosure Statement for Medical Device Security
08/06/2013 Software/
Informatics		 13-60 Complete IEC TS 62443-1-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013 Software/
Informatics		 13-62 Complete IEC TR 62443-3-1 Edition 1.0 2009-07 Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
05/29/2024 Software/
Informatics		 13-134 Complete ISO IEEE 11073-10404 Second edition 2022-12 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
IEEE Std 11073-10407-2020 Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
01/14/2019 Software/
Informatics		 13-106 Complete IEEE Std 11073-10207-2017 Health informatics - Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication
01/15/2013 Software/
Informatics		 13-35 Complete ANSI AAMI SW87:2012 Application of quality management system concepts to medical device data systems
01/27/2015 Software/
Informatics		 13-70 Complete ANSI AAMI IEC TIR80001-2-5:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
IEC TR 80001-2-5 Edition 1.0 2014-12 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
08/21/2017 Software/
Informatics		 13-88 Complete ISO IEEE 11073-10417 Third edition 2017-04 Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
01/15/2013 Software/
Informatics		 13-33 Complete AAMI TIR 36:2007 Validation of software for regulated processes
04/04/2016 Software/
Informatics		 13-81 Complete ISO IEEE 11073-10419 First edition 2016-06-15 Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump
IEEE Std 11073-10419:2015 Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
10/19/2020 Software/
Informatics		 13-116 Complete FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0
 
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